Utility of Mucosal Impedance Device in Chronic Esophageal Disorders:

NCT07227506 | Recruiting FDA Device

• 1 other identifier: PRO00055595
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Background \& Significance Chronic benign esophageal disorders such as Gastroesophageal reflux disease (GERD) and eosinophilic esophagitis are common gastrointestinal disorders affecting nearly 20% and 0.1% of the population, respectively. Although these conditions are frequent, the diagnosis of GERD or EoE requires complex decision making involving endoscopic examination, histopathological examination, and esophageal pH testing. This translates into significant economic burden; For example, burden due to GERD is about $24 billion annually. Additionally, there may be a delay in the diagnosis of GERD or EoE as Investigators might have to do multiple procedures such as upper endoscopy, esophageal pH testing, etc for the same participant for confirmation of the diagnosis. In addition, there could be overlay between GERD and EoE in the diagnosis which make cause delay in the diagnosis and decision making. Aim: Here, Investigators will plan to identify the diagnostic utility and cost-effectiveness of this novel Mivu device(FDA approved) in the diagnosis of gastroesophageal reflux disease or chronic esophageal inflammatory disorders in participants with reflux symptoms or chronic esophageal symptoms.

Conditions

Gerd; Eosinophilic Esophagitis

Keywords

gerd; eosinophilic esophagitis

Outcome Measures

Primary Outcomes (2)

• Diagnostic accuracy of MuVI

  Sensitivity and Specificity of MuVI

  1 year

• Diagnostic utility of mucosal impedance in the diagnosis of GERD

  Correlation of esophageal pH parameters with mucosal impedance data.

  1 year

Study Arms (2)

True GERD

Positive endoscopy findings or esophageal pH results based on Lyon 2.0

Device: MuVI Esophageal mucosal impedance testing

Functional Heartburn

Negative endoscopy and negative esophageal pH testing results

Device: MuVI Esophageal mucosal impedance testing

Interventions

MuVI Esophageal mucosal impedance testing DEVICE

Esophageal mucosal impedance values are checked in both groups

Functional Heartburn; True GERD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All the patients with reflux symptoms or dysphagia/esophageal symptoms who undergo upper endoscopy will be enrolled into the study.

You may qualify if:

• \. Patients with chronic esophageal symptoms such as atypical or typical reflux symptoms and dysphagia, is here for upper endoscopy testing.

You may not qualify if:

• Presence of esophageal stricture
• Unstable patients who cannot undergo this testing.
• Patients on anticoagulation on the day of procedure.
• Presence of esophageal cancer.
• Pregnancy.
• Minor patients.

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Related Publications (3)

• Choksi Y, Lal P, Slaughter JC, Sharda R, Parnell J, Higginbotham T, Vaezi MF. Esophageal Mucosal Impedance Patterns Discriminate Patients With Eosinophilic Esophagitis From Patients With GERD. Clin Gastroenterol Hepatol. 2018 May;16(5):664-671.e1. doi: 10.1016/j.cgh.2017.12.020. Epub 2017 Dec 14.

  PMID: 29248733 RESULT

• Patel DA, Higginbotham T, Slaughter JC, Aslam M, Yuksel E, Katzka D, Gyawali CP, Mashi M, Pandolfino J, Vaezi MF. Development and Validation of a Mucosal Impedance Contour Analysis System to Distinguish Esophageal Disorders. Gastroenterology. 2019 May;156(6):1617-1626.e1. doi: 10.1053/j.gastro.2019.01.253. Epub 2019 Jan 31.

  PMID: 30711626 RESULT

• Maresova P, Rezny L, Hruska J, Klimova B, Swanstrom LL, Kuca K. Diagnosis and treatment of patients with gastroesophageal reflux disease - a systematic review of cost-effectiveness and economic burden. BMC Health Serv Res. 2024 Nov 6;24(1):1351. doi: 10.1186/s12913-024-11781-8.

  PMID: 39501242 RESULT

MeSH Terms

Conditions

Gastroesophageal Reflux; Eosinophilic Esophagitis

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Esophagitis; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Gokulakrishnan Balasubramanian

CONTACT

414-805-3827; gbalasubramanian@mcw.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 11, 2025
• First Posted: November 12, 2025
• Study Start: November 20, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: November 13, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)